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Jia-Yi Wu,1,2,* Zhen-Yu Yin,3,* Yan-Nan Bai,1,2 Yu-Feng Chen,4 Song-Qiang Zhou,1,2 Shuang-Jia Wang,5 Jian-Yin Zhou,6 Yi-Nan Li,2 Fu-Nan Qiu,1,2 Bin Li,5 Mao-Lin Yan1,2 1Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian Province, 350001, People’s Republic of China; 2Department of Hepatobiliary Pancreatic Surgery, Fujian Provincial Hospital, Fuzhou, Fujian Province, 350001, People’s Republic of China; 3Department of Hepatobiliary Surgery, Xiamen Traditional Chinese Medical Hospital, Xiamen, Fujian Province, 361000, People’s Republic of China; 4Department of Hepatobiliary Surgery, The Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian Province, 363000, People’s Republic of China; 5Department of Hepato-Biliary-Pancreatic and Vascular Surgery, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian Province, 361000, People’s Republic of China; 6Department of Hepatobiliary Surgery, Zhongshan Hospital of Xiamen University, Xiamen, Fujian Province, 361000, People’s Republic of China*These authors contributed equally to this workCorrespondence: Mao-Lin Yan; Bin Li Tel +86 0591-88217130; +86 13606056652Fax +86 0591-87557768; +86 0592-2132222Email yanmaolin74@163.com; wasalee@126.comBackground: Lenvatinib (LEN) combined with anti-PD-1 antibodies (PD-1) exerted promising effects on unresectable hepatocellular carcinoma (uHCC). We assessed the safety and clinical efficacy of triple therapy [LEN+PD-1+transcatheter arterial chemoembolization (TACE)] in uHCC.Methods: uHCC patients with an ECOG PS score of 0– 1 and Child–Pugh class A who underwent triple therapy were included. The primary endpoint was objective response rate (ORR) based on mRECIST. Secondary endpoints were conversion rate to liver resection and treatment-related adverse events.Results: Between November 2018 and December 2020, 62 uHCC patients who underwent triple therapy at four major cancer centers in China were analyzed, including 35 in BCLC-C, 21 in BCLC-B, and 6 in BCLC-A. With a median follow-up of 12.2 months (range, 7.6– 33.3 months), the investigator and blinded independent central review-assessed ORR were 80.6% and 77.4%, respectively. A total of 33 patients (53.2%) reached the standard of conversion to resectable HCC and 29 patients underwent resection. The median interval between start of triple therapy and resection was 123 days (range, 55– 372 days). Pathological complete response and major pathological response were observed in 16 and 24 patients, respectively. Median overall survival and progression-free survival were not reached. Treatment-related adverse events occurred in 74.2% of the patients (grade ≥ 3, 14.5%; grade ≥ 4, 4.8%).Conclusion: Combination of LEN, PD-1 and TACE showed a high rate of tumor response and convert resection in uHCC patients, with manageable toxicity.Keywords: unresectable hepatocellular carcinoma, tumor response, adverse events, combination therapy, monotherapy |
